Stocks In Focus

GenMark Diagnostics, Inc (NASDAQ: GNMK) announced FDA 510(k) market clearance for its ePlex Blood Culture Identification Gram-Positive, or BCID-GP, panel. This panel along with ePlex Blood Culture Identification Gram-Negative, or BCID-GN and Fungal Pathogen, or BCID-FP, is used to diagnose and manage blood stream infections that can lead to sepsis.

The stock advanced 8.14 percent to $4.25 in after-hours trading.

Akorn Names Pharma Veteran Boothe as CEO

Akorn, Inc. (NASDAQ: AKRX) announced the appointment of pharma industry veteran Douglas Boothe as its president and CEO, effective Jan. 1, 2019.

Proteostasis Therapeutics Inc (NASDAQ: PTI) said it would now report complete efficacy and safety data from the Phase 1 study of its proprietary combination therapy triplet, namely PTI-808, PTI-801 and PTI-428, and the from the high-dose doublet study in subjects with cystic fibrosis in the first quarter of 2019. This is a deviation from the company's plan of reporting preliminary results from the triplet study by dose cohort, as each cohort was completed, beginning with a low-dose cohort.

The stock slumped 21.90 percent to $3.21 in after-hours trading.

Biopharmx Gets Grace Period For Regaining Compliance

Biopharmx Corp (NYSE: BPMX), which is found violating NYSE American continued listing standards with respect to stockholder's equity, said the NYSE Regulation has received its compliance plan and granted a plan period through Sep. 24, 2019.

Pfizer Discontinues Mid-stage Trial of Anti-bacterial Vaccine

Pfizer Inc. (NYSE: PFE) announced discontinuation of its Phase 2b trial dubbed STRIVE that is evaluating its investigational Staphylococcus aureus multi-antigen vaccine due to determination by an independent Data Monitoring Committee that the study reached futility, ie there is a low statistical probability for the study to meet the pre-defined primary efficacy objective in adults undergoing elective spinal fusion surgery after completing a planned Phase 3 expansion of the study.

However, the committee found the investigational vaccine to be safe and well tolerated. Pfizer said it is evaluating the next steps for the potential development of a Staphylococcus Aureus vaccine.

Merck & Co., Inc. (NYSE: MRK) said the FDA has extended the PDUFA action date for the sBLA for its Keytruda, being evaluated as monotherapy for first-line treatment of locally advanced, or metastatic non-small cell lung cancer, whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.

The extension comes due to the additional time FDA will need to review the additional data and analyses the company submitted to the agency, which constitutes a major amendment.

The new PDUFA date is April 11, 2019.

Apellis' C3 Glomerulopathy Therapy Granted Orphan Drug Designation

Apellis Pharmaceuticals Inc (NASDAQ: APLS) said its C3 component inhibitor APL-2 has been granted orphan drug designation for treating C3 glomerulopathy. The designation is granted to novel drugs that are tested for rare diseases affecting fewer than 200,000 people in the US., and accords privileges such as development and commercial incentives, including seven years of market exclusivity in the U.S., consultation by FDA on clinical study design, potential for expediting drug development and certain fee exemptions and reductions.

Merus

Merus NV (NASDAQ: MRUS) said it has reached a settlement of all pending patent litigation and administrative proceedings with Regeneron Pharmaceuticals Inc (NASDAQ: REGN) regarding certain antibody generation platforms of each company.

The agreement provides for signing of a global patent cross-license and a $15 million investment in Merus by Regeneron through purchase of 600,000 Merus shares at $25 per share.

Arca Biopharma Inc (NASDAQ: ABIO) said it has submitted an amendment to the Special Protocol Assessment request to the FDA, with the amendment addressing FDA feedback and guidance on the target population for its planned Phase 3 trial.

"The SPA request is part of the Company's ongoing interaction with the FDA focused on the planned Phase 3 clinical development program of Gencaro (bucindolol hydrochloride) as a genetically-targeted treatment for atrial fibrillation in patients with heart failure," the company said.

The stock jumped 11.47 percent to 37.9 cents in after-hours trading.

PLx Pharma to Raise $15M Through Convertible Preferred Stock Offering

PLx Pharma announced an agreement with Park West Asset Management, under which the latter would purchase 15,000 shares of newly issued Series A convertible preferred stock, grossing proceeds of $15 million for the former.

PLx said it will use the proceeds to advance Vazalore to market readiness among other things.